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OpenTrials
Completed

NCT Number: NCT00279981

TRENDS: A Prospective Study of the Clinical Significance of Atrial Arrhythmias Detected by Implanted Device Diagnostics

The purpose of this study is to look at the heart rate and rhythm information collected daily in Medtronic implantable pulse generators (IPG), implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy (CRT) devices. The study will gather this information from many patients to see if heart rate or rhythm data can predict the risk of a patient having a medical condition such as stroke.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Heart Failure Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Liverpool, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject provides written informed consent and privacy/protection authorization.
  • Subjects 65 years of age or older.

OR

  • Subjects with age >18 and < 65 years and one of the following stroke risk factors:
  • Prior stroke or TIA
  • Diagnosis of hypertension (HTN)
  • Diagnosis of Diabetes Mellitus (DM)
  • Diagnosis of Congestive Heart Failure (CHF)
  • Subjects who meet the Class I/Class II indications for a dual chamber implantable pulse generator or dual chamber implanted cardioverter defibrillator device

OR

  • Subjects who meet the criteria for indication of a dual chamber resynchronization device with bi-ventricular pacing (moderate to severe CHF symptoms [NYHA Class III-IV] despite optimal medical therapy, left ventricular ejection fraction ≤ 35%, and a QRS duration ≥130 ms)13.

Exclusion criteria

  • Subjects who are to receive a replacement IPG, ICD or CRT device.
  • Subjects with chronic (permanent) AT/AF.
  • Subjects with a history of AV nodal dependent arrhythmias.
  • Subjects with a terminal illness who are not expected to survive more than 6 months.
  • Subjects who are unwilling or unable to cooperate or give written informed consent and privacy/protection authorization, or subjects whose legal representatives or legal guardians refuse to give informed consent or privacy/protection authorization.
  • Subjects currently receiving treatment in another drug and/or device study which could affect the outcome of the trial.
  • Subjects who are or will be inaccessible for follow-up at a qualified study center.

Treatment and study plan

Diagnostic

Device

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Collaborators

  • Medtronic

Registry information

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Jan 20, 2006
Registry last updated
Dec 11, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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